MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; ROLLATOR,BASIC,STEEL,6",BURGUNDY

Catalog Number MDS86850ES

Device Problem Material Integrity Problem (2978)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/08/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer "they were sitting on the seat of the rollator when one of the wheels suddenly snapped off".Per the customer "they fell onto the floor and suffered serious personal injuries," described as "compression fractures in their spine and associated medical complications".Per the customer the device was purchased from medline through their insurance provider.No additional information is available at this time.The sample was requested for evaluation.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the customer "they were sitting on the seat of the rollator when one of the wheels suddenly snapped off".

Manufacturer Narrative

Updated: b4, d2, d4, g3, g6, h2.

• Type of Device: ROLLATOR,BASIC,STEEL,6",BURGUNDY
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17002062
• MDR Text Key: 315926087
• Report Number: 1417592-2023-00234
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86850ES
• Device Lot Number: 88522020001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/08/2023
• Initial Date FDA Received: 05/25/2023
• Supplement Dates Manufacturer Received: 10/09/2023
• Supplement Dates FDA Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other